Dairy Products and Metabolic Effects (Norwegian Part)

Heart Disease Clinical Trial

Official title:

Dairy Products and Metabolic Effects - A Multicentre Nordic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140816
• Other study ID #: Melk61015
• Status: Completed
• Phase: N/A
• First received: August 30, 2005
• Last updated: July 3, 2011
• Start date: September 2005
• Est. completion date: November 2008

Study information

• Verified date: February 2009
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Foods containing more dairy fat (and thus a higher proportion of short and medium chain fatty acids and possibly some other nutrients or micronutrients with effect on energy intake, satiety or energy metabolism) affect energy balance and metabolic profile in subjects prone to develop abdominal adiposity and metabolic syndrome.

The aim of the study is to test the hypothesis that intake of dairy products has a favorable effect on markers of the metabolic syndrome.

To explore such a hypothesis the participants have to be in a free living situation during an extended study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

Apparently healthy men and women aged 30-65 years with:

• BMI < 35 kg/m2.

• Having signed a written informed consent

• Limited habitual intake of dairy products according to dietary questionnaire.

• Traits of the metabolic syndrome - two or more of the following criteria fulfilled:

• Fasting plasma glucose = 6.1 mmol/l

• Serum triglycerides = 1.7 mmol/l

• Serum HDL cholesterol < 1.0 mmol/l (40 mg/dl) (men) and < 1.3 mmol/l (50 mg/dl) (women)

• Blood pressure =130/ 85 mmHg

• Waist circumference >94cm (men) and >88cm (women).

Exclusion Criteria:

Patients with any of the following conditions will not be included in the trial:

• Known Type 1 diabetes, or treated type 2 diabetes.

• With HbA1c = 7,5% at the first blood sample.

• Pregnant or lactating women.

• Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.

• Having received an investigational drug in the last 30 days before date of randomisation.

• Unable or unwilling to comply with the protocol.

• Likely to withdraw from the study before its completion.

Concomitant medications:

• With a lipid lowering drug (fibrate, statin) within the last 6 weeks before randomisation.

• Treated with antidiabetic drugs.

• Treated with Cyclosporin A.

• Change within the last 6 weeks before randomisation and during the study in the medications that could interfere with the lipid profile (i.e., anti- hypertensive drugs, oral corticosteroids, thyroid hormones, retinoids, thiazidic derivative, hormone replacement therapy).

• Treated with oral anticoagulants.

• Treated with protease inhibitors (indinavir, ritonavir, saquinavir)

• Treated against obesity: medical treatment within the last 6 weeks (orlistat, sibutramine) and/or surgery (gastroplasty, bypass).

Associated diseases or conditions:

• Diabetic ketoacidosis, diabetic pre-coma.

• Current chronic pancreatitis, or identified risk or known history of acute pancreatitis.

• Hepatic insufficiency, acute alcohol intoxication, alcoholism.

• Known cholelithiasis without cholecystectomy.

• AST and/or ALT > 2 times the upper normal limit (UNL).

• Renal failure or renal dysfunction defined by serum creatinine levels > 135 µmol/L in males and > 110 µmol/L in females.

• Recent myocardial infarction (within 3 months prior to randomisation),

• Known gastric or peptic ulcer or intestinal disease within the previous 3 months of randomisation capable of modifying the intestinal absorption of the drugs.

• Any other severe pathology such as cancer, mental illness, etc, which in the opinion of the investigator might pose a risk to the patient or confound the results of the study.

• Blood pressure >160/100 mmHg.

• Body weight changes exceeding ± 5% of total body weight during the last three months before admission. Drugs affecting lipid and glucose metabolism, weight reducing drugs, antihypertensives and other drugs with known metabolic effects.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Disease
• Metabolic Syndrome X

Intervention

Behavioral:
• Increased intake of dairy products

Locations

Country	Name	City	State
Norway	Lipidklinikken, Medisinsk avdeling, Rikshospitalet	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Oslo University Hospital	Opplysningskontoret for meieriprodukter., The Research Council of Norway, Tine, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight
Primary	Body mass index (BMI)
Primary	Waist circumference/sagittal abdominal diameter
Primary	Proportion of body fat (bioelectrical impedance analysis [BIA], dual energy x-ray absorptiometry [DEXA])
Primary	Serum lipids (triglycerides [TG], cholesterol [chol], high-density lipoprotein [HDL] chol, low-density lipoprotein [LDL] chol, apolipoprotein (apo) B, apo A1, fatty acid composition)
Primary	Blood glucose, HbA1c%
Primary	Serum insulin, C-peptide
Primary	Blood pressure (systolic blood pressure [SBP], diastolic blood pressure [DBP])
Primary	Marker of fibrinolysis: plasminogen activator inhibitor [PAI-1]
Primary	Markers for inflammation: micro C-reactive protein (microCRP), interleukin-6 (IL-6), 15-keto-DH-prostaglandin F2 alfa (in urine), fibrinogen
Primary	Markers of endothelial function: vascular cell adhesion molecule (VCAM), vWillebrand factor
Primary	Lipid peroxidation ("oxidative stress"): 8-F2-isoprostanes (in urine)
Secondary	Adiponectin, leptin
Secondary	LDL particle size
Secondary	Gene expression in leukocytes
Secondary	Direct measurement of insulin sensitivity
Secondary	Glucose tolerance test (0, 30, 60, 90, 120)
Secondary	Fat load test (0, 4, 6)
Secondary	Serum free fatty acids (FFA)
Secondary	Fat content of faeces
Secondary	Polymorphisms in genes with direct influence on relation between endogen lipid synthesis and lipid oxidation (AMP-kinase, SREBP1c, stearoyl desaturase-SCD1, acetyl-CoA carboxylase-ACC2, acyl-CoA synthetase-ACS1)